BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    QUICK-CARE BIOPSY NEEDLE

    K Number: K973565 · Decision Nov 3, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    207
    Registration Numbers
    207
    Same Product Code
    360
    Applicant Total
    190
    Review Days
    45

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    QUICK-CARE BIOPSY NEEDLE
    K Number
    K973565
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1075
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cook, Inc.
    Date Received
    September 19, 1997
    Decision Date
    November 3, 1997
    Product Code
    KNW
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KNW Instrument, Biopsy

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (KNW), ordered by most recent decision date.

    Promisemed VeriEcto Automatic Biopsy Needles

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Control Module; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Disposable Probe, 8 gauge; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Disposable Targeting Set, 8 gauge; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Foot Switch; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Reusable Tray; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Battery Char

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ZeniCore™ Automatic Biopsy Instrument (863212100 / ZeniCore Automatic Biopsy Device 12ga x 10cm with Coaxial Introducer Kit); ZeniCore™ Automatic Biopsy Instrument (863212130 / ZeniCore Automatic Biopsy Device 12ga x 13cm with Coaxial Introducer Kit); ZeniCore™ Automatic Biopsy Instrument (863214100 / ZeniCore Automatic Biopsy Device 14ga x 10cm with Coaxial Introducer Kit); ZeniCore™ Automatic Biopsy Instrument (863214130 / ZeniCore Automatic Biopsy Device 14ga x 13cm with Coaxial

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    EnCor EnCompass™ Breast Biopsy and Tissue Removal System

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Resitu Slider 09 (RESL09)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Forcyte Autograft Harvest Kit

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology
    View all

    Other Clearances by Cook, Inc.

    K Number Device Name
    K133130 BEACON TIP TORCON NB ADVANTAGE CATHETER, TORCON NB ADVANTAGE CATHETER
    K140593 ADVANCE SALIVARY BALLOON CATHETER WITH WIRE GUIDE
    K132592 FLEXOR RADIAL HYDROPHILIC INTRODUCER ACCESS SET
    K133597 CIAGLIA PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET/TRAY, CIAGLIA BLUE RHINO PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET/TRAY
    K131772 CANTATA(R) 2.9 MICROCATHETER
    K131204 ADVANCE CS CORONARY SINUS INFUSION CATHETER
    K133634 SPECTRUM TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SET
    K132020 ADVANCE 34LP LOW PROFILE PTA BALLOON DILATATION CATHETER
    K131201 ENTUIT SECURE GASTROINTESTIONAL SUTURE ANCHOR SET, ENTUIT SECURE ADJUSTABLE GASTROINTESTINAL SUTURE ANCHOR SET
    K131206 COOK CERVICAL RIPENING BALLOON
    Search all 190 clearances from Cook, Inc. →